Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of
BioMedReports.com, the FDA Calendar has expanded to include the following additional categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
SkyePharma (UK: SKP.L) (US: SKYEF.PK) has a pending NDA for a new asthma drug, Flutiform, which is the Company's most important pipeline product. On 5/22/09, SkyePharma announced that the NDA was accepted for review by the FDA and noted that the regulatory review timeline for asthma treatments is typically longer than the standard 10-month PDUFA decision deadline of 1/23/10.
On 6/9/09, SkyePharma provided info on FDA communication in the form of a 74-day letter which confirmed that the NDA is sufficiently complete to permit a review. However, the FDA has given preliminary notice of potential review issues which the Company stated will likely require additional clinical work to provide more data on Flutiform dosing. The potential FDA review issues are not expected to have an impact upon the development of Flutiform for Europe or Japan.
Par Pharma (NYSE: PRX): On 6/10/09, MonoSol Rx, announced that the new drug application (NDA) for ondansetron orally dissolving film strip (ODFS) has been accepted for review by the FDA with an expected PDUFA action date during 1Q10. Ondansetron ODFS was developed using MonoSol Rx's proprietary PharmFilm technology to deliver the anti-emetic therapy ondansetron in a thin film strip that rapidly dissolves on the tongue. MonoSol Rx and its partner Strativa Pharma (the proprietary products division of PRX) are seeking FDA approval of ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.
